Kornimate/medical-research-clean huggingface dataset:
measuring outcomes in patients with pulmonary arterial hypertension not on active treatment (motion)

Conditions: Hypertension, Pulmonary

Summary: the motion study was a prospective, phase iv study for patients with pulmonary arterial hypertension (pah). the study was designed to further explore patient-reported outcomes in pah subjects who were not on active treatment and living in the united states. in addition, the study explored the use of new telemetric technology (accelerator band) to evaluate if this technology correlates with improvements in 6 minute walking distance 6mwd in patients with pah.


Eligibility criteria:
inclusion criteria: * male or female patients, 18 to 80 years of age at visit 0 * women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the risk evaluation mitigation strategies (rems) guidance * symptomatic pulmonary arterial hypertension, world health organization group 1 with a pulmonary vascular resistance (pvr) \>300 dyn\*sec\*cm-5, mean pulmonary artery pressure (pap mean) ≥25 mmhg, and pulmonary capillary wedge pressure (pcwp) ≤15 mmhg as assessed by right heart catheterization within 6 months prior to screening (visit 0) * pah of the following types: idiopathic (ipah) familial (fpah) associated with pah (apah) due to: connective tissue disease congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment anorexigen or amphetamine use portal hypertension with liver cirrhosis * not treated with pah-specific pulmonary medications within 14 days of screening (visit 0) * 6mwd between 150 meters and 450 meters exclusion criteria: * patients who are pregnant * patients currently on nitrate and/or nitric oxide (no) donor therapy; patients currently taking phosphodiesterase 5 (pde5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific pde inhibitors (theophylline, dipyridamole) * non-who group 1 pulmonary hypertension * severe restrictive lung disease * history of uncontrolled high blood pressure or hypotension * a medical disorder, condition, or history that in the opinion of the investigator would impair their ability to participate or complete this study * active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization

Keywords: pulmonary hypertension,riociguat,living with pulmonary hypertension questionnaire
clinical and microbiological evaluation of laser assisted new attachment procedure (lanap) using nd:yag vs. diode laser in the management of stage ii periodontitis

Conditions: Periodontal Diseases

Summary: the aim of the present study is to compare the efficacy of lanap to conventional scaling and root planing in the management of stage ii periodontitis.


Eligibility criteria:
inclusion criteria: * patients with stage ii generalized periodontitis ppd ≥ 5 mm with attachment loss 3-4 mm with horizontal bone loss exclusion criteria: * patients with vertical bone loss or furcation involvement. * history of smoking more than (10 cigarettes / day). * patient with medical condition that contraindicate surgical procedures. * patients receiving antibiotics in the past three months prior to the procedure. * pregnant or lactating females.
peanut reactivity reduced by oral tolerance in an anti-ige clinical trial

Conditions: Peanut Allergy; Food Allergy

Summary: the investigators will perform a double blind, placebo controlled clinical trial with xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. the investigators will determine if pretreatment with anti-ige mab (xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

36 subjects will receive xolair, and 8 subjects will receive placebo. the study will occur at 4 sites: boston children's hospital, children's hospital of philadelphia, stanford university and lurie children's hospital. patients will be pre-treated with xolair or placebo before rapid oral peanut desensitization. patients will continue to receive xolair during the 8 subsequent weeks of desensitization, receiving their final dose of xolair one week after reaching the highest tolerated dose of peanut.

Eligibility criteria:
inclusion criteria: * moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old. * sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater) * immunocap ige level to peanut \> 10 ku/l. * sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (dbpcfc) at maximum of cumulative 175 mg of peanut protein dose. exclusion criteria: * subjects with a total ige at screening of \ 2,000 ku/l. * positive reaction to the placebo on dbpcfc. * previous reaction to omalizumab. * subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an icu, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.

Keywords: xolair omalizumab peanut oral desensitization
a survivorship care plan and embedded navigation tool

Conditions: Prostate Cancer

Summary: this is a parallel group, multisite prospective clinical study. the purpose of this study is to evaluate whether ascent enables patients to adhere to the survivorship guidelines and improves coordination of care to address patient needs.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prostate adenocarcinoma * age ≥18 years * receiving curative intent radiotherapy for prostate cancer (note: post-operative radiotherapy \[i.e., "adjuvant" or "salvage radiotherapy subsequent to prostatectomy\] is allowed.) * subjects will be enrolled within two weeks prior to and two weeks after the final fraction of radiotherapy. * receiving androgen deprivation therapy (adt) for a duration of ≥3 consecutive months as follows: * gnrh agonist or antagonist (medical castration), with or without an anti-androgen (i.e., bicalutamide, flutamide, nilutamide, etc.), or * bilateral orchiectomy (surgical castration) * technology requirement: candidates must have access to the internet * able to understand and willing to sign a written informed consent document. * able to speak and understand english, in the opinion of the treating physician. exclusion criteria: * significant concurrent medical or psychiatric condition that would interfere with the patient's ability to abide by the study protocol or cooperate fully with the protocol requirements, including completion of survey and assessment
withings ecg-monitor study

Conditions: Atrial Fibrillation

Summary: the aim of the study is to evaluate the performance of withings wbs08 with embedded withings ecg monitor in the automatic detection of atrial fibrillation


Eligibility criteria:
inclusion criteria: * male or female who are 22 years of age or older, * subject able to read, understand, and provide written informed consent, * subject willing and able to participate in the study procedures as described in the consent form, * subject able to communicate effectively with and willing to follow instructions from the study staff. exclusion criteria: * vulnerable subject with regard to regulations in force * subject who is deprived of liberty by judicial, medical or administrative decision, * underage subject, * legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form. * subject within several of the above categories, * subject who refused to participate in the study, * subject mentally impaired resulting in limited ability to cooperate * subject with electrical stimulation by pacemaker * patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able to hold still (e.g parkinson disease) * patient unable to stay in an upright position for the duration of study measures * acute myocardial infarction (mi) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, may increase the risk to the subject or renders data uninterpretable (e.g., recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) * acute pulmonary embolism or pulmonary infarction, within 90 days of screening * stroke or transient ischemic attack within 90 days of screening * active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block). * history of life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block) * symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites * known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ecg) electrodes including known allergy or sensitivity to fluoroelastomer bands * weight more than 180 kg

Keywords: mhealth atrial fibrillation
treatment of hot flushes in asian women with ultra-low dose estradiol patch

Conditions: Hot Flashes

Summary: 150 postmenopausal asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. the women will be randomly assigned to one of two treatment groups (menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * evidence of postmenopausal status exclusion criteria: * contraindication to estrogen therapy

Keywords: menopause
to evaluate antiviral efficacy of telbivudine in hepatitis b antigen positive (hbeag-positive) compensated chronic hepatitis b (chb)

Conditions: Hepatitis B, Chronic

Summary: this study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. antiviral efficacy is assessed by hepatitis b virus (hbv) dna non-detectability (pcr \<300 copies/ml) by week 104 with chb.


Eligibility criteria:
inclusion criteria: male or female, at least 18 yrs of age; hbsag positive, hbeag positive and anti-hbe negative at the time of screening; quantifiable serum hbv dna levels of \>105copies/ml; alt levels any level; treatment naïve; baseline liver histology in case of alt levels within normal limits performed within last 12 months) indicative of chronic hepatitis b changes metavir score f \>2; willing and able to comply with the study drug regimen and all other study requirements; the patient or guardian is willing and able to explore written informed consent to participate in the study. exclusion criteria: patient is pregnant or breastfeeding. women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hcg) at screening visit; patient is of childbearing potential (men and women) and unwilling to use a barrier method of contraception. it is required that a barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of childbearing potential (men and women) regardless of whether a hormonal agent also is used as a method of contraception; patient is co infected with hepatitis c virus (hcv), hiv. patients will be tested for antibodies to hcv \& hiv in the screening assessments;patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir; patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years; patient has a medical condition that requires frequent or prolonged use of systemic corticosteroids; patients who has been on warfarin or other anticoagulants during 30 days prior to screening or if expected during the present study; patient has any other concurrent medical condition, at clinician's discretion, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study other protocol defined inclusion/exclusion criteria may apply

Keywords: hepatitis b, chronic, hepatitis b e antigen positive, adults, telbivudine, adefovir
hemocoagulation and lipoperoxidation in women using combined oral contraceptives, correction by antioxidants

Conditions: Polycystic Ovarian Syndrome; Hyperandrogenism; Menstrual Irregularities

Summary: we investigate parameters of hemocoagulation and lipoperoxidation in women using combined oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants

it is well known that hormonal contraceptives using increase risk of thrombosis. we conduct parameters of hemostasis in women that use combined oral contraceptives with antiandrogenic activity for contraception and treatment. considering relationship between lipoperoxidation in platelets and hemostasis we expect that limitation of lipoperoxidation by antioxidants can restrict hypercoagulation and decrease risk of thrombosis. the purpose of this study is decrease of thrombosis risk in women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone, 30 mcg ethinylestradiol/3 mg drospirenone, 35 mcg ethinylestradiol/2mg cyproterone acetate. half of the women of each arm (group) receive only combined oral contraceptives (coc), other women receive combined oral contraceptives and antioxidant complex selmevit. the blood tests conduct on 19-21 days of the menstrual cycle before coc use (control group) or on 19-21 days of coc use after 1, 3, 6 and 12 cycles. also we investigate subjective tolerability, therapeutic effects, menstrual cycle control and adverse effects of cocs in women that have or have no antioxidant complex selmevit

Eligibility criteria:
inclusion criteria: * women aged 18-35 years * absence of contraindications for coc use * informed voluntary consent for examination exclusion criteria: * age younger than 18 and older than 35 years * refusal or failure to comply with the study protocol * drug or alcohol dependence * psychiatric diseases * severe somatic and allergic diseases * pregnancy * malignancies * taking drugs that affect haemostasis, including hormonal contraceptives during 6 months before study beginning * cases of thrombosis among first-line relatives in family history * contraindications to the coc use under eligibility criteria of hormonal contraception (who, 2012)

Keywords: combined oral contraceptives drospirenone cyproterone hemostasis antioxidants
covid-impact "psychological impact of covid-19 on ap-hp staff"

Conditions: Post Traumatic Stress Disorder (PTSD); Anxiety; Depression; Epidemic Disease; COVID19

Summary: the epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the assistance publique - hôpitaux de paris (ap-hp) . to this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the ap-hp and hospitals level. the objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (ptsd), and depressive episodes as defined in the dsm-5. this study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. the results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. the main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.


Eligibility criteria:
inclusion criteria: * ap-hp professionals on duty during the covid epidemic agreeing to participate in the three stages of the study. exclusion criteria: * none

Keywords: prevalence post-traumatic stress disorder (ptsd), epidemic covid19
a study of levetiracetam in japanese pediatric patients with generalized tonic-clonic seizures

Conditions: Epilepsy; Generalized Tonic-clonic Seizures

Summary: to evaluate the efficacy and safety of levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in japanese pediatric patients aged ≥4 to \<16 years with uncontrolled generalized tonic-clonic (gtc) seizures despite treatment with 1 or 2 anti-epileptic drugs (aeds).


Eligibility criteria:
inclusion criteria: * an epileptic patient with generalized tonic-clonic seizures that are classifiable according to the international league against epilepsy classification of epileptic seizures (epilepsia, 1981) * a patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the combined baseline period and during the combined baseline period exclusion criteria: * presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures * diagnosis of lennox-gastaut syndrome * confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features * a history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to visit 1

Keywords: levetiracetam epilepsy generalized tonic-clonic seizures
mek inhibitors for the treatment of hypertrophic cardiomyopathy in patients with rasopathies

Conditions: Cardiomegaly; Noonan Syndrome

Summary: the goal of this study is to evaluate the effectiveness of trametinib treatment in patients with hyperthropic cardiomyopathy and a genetic mutation in the ras/mapk pathway.

introduction rasopathies are a group of genetic diseases caused by mutations in the mitogen-activated kinase (ras-mapk) pathway. these mutations affect many processes and are the cause of numerous genetic syndromes (including noonan syndrome) in the course of which severe hypertrophic cardiomyopathy (hcm) develops. mek kinase inhibitors are used to treat cancers with mutations in the ras-mapk pathway in adults. so far, single cases of hcm treatment in patients with rasopathies have been described, with rapid improvement in both laboratory and echocardiographic parameters and regression of myocardial hypertrophy. due to the described effectiveness, it is reasonable to verify these effects in a well-designed randomized study on a large group of patients. objective to evaluate the effectiveness of trametinib treatment in patients with hcm and a genetic mutation in the ras/mapk pathway. methodology randomized, open-label study. the study will include patients aged 0 to 18 with: * mutation in the ras/mapk pathway confirmed by genetic tests * hcm diagnosed by echocardiography in the first phase of the study (3 months), patients will be randomly assigned to one of two groups: * the intervention group will receive trametinib and standard treatment (beta-blocker and disopyramide) * the control group will receive only standard treatment. once this phase is complete, patients will be assessed. if higher effectiveness is demonstrated in the intervention group, in the second phase of the study, patients in the intervention group will continue their current treatment and patients in the control group will receive trametinib treatment. each group will receive trametinib for 12 months. importance of the study the study results will provide grounds for routine introduction of mek kinase inhibitors for the treatment of patients with hcm due to rasopathy. if effectiveness is demonstrated, this group will gain a simple, non-invasive and causal treatment option.

Eligibility criteria:
inclusion criteria: * patient with diagnosed rasopathy * patient with diagnosed hypertrophic cardiomyopathy * signed innform consent exclusion criteria: * contraindications to treatment with propranolol (drug hypersensitivity, atrioventricular block, severe bradycardia) disopyramide (drug hypersensitivity, wpw syndrome, atrioventricular block, qt prolongation) trametinib (drug hypersensitivity) * lack of consent of the child's guardians to participate in the study

Keywords: noonan syndrome mek kinase rasopathies children cardiomyopathy
the effects of reaching task following selective trunk stability exercise

Conditions: Cerebral Stroke; Hemiplegia, Spastic

Summary: this study is performed in a controlled randomized, two-period crossover design to test the efficacy of abdominal drawing-in maneuver (adim) exercise compared to conventional physiotherapy in chronic stroke survivors.

all participants provided written informed consent and are assigned to group a or group b. the inclusion criteria are exclusion criteria are abdominal drawing-in maneuver exercise is following as: it's for strengthening the transversus abdominis muscle(tra). the simple device, that observes the pressure changes by the gauge. subjects receive intervention 2 times a week for 4 weeks. each session is 40 minutes. from the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the stabilizer™ pressure biofeedback that stabilizes transversus abdominis muscle. at this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising the device assists in body control movements of the spine and abdominal muscle. conventional physiotherapy is following as: release pain, limb stretching, mobilization of joint and pelvic movement. subjects receive 2 times a week for 4 weeks. each session is 40 minutes. group a received abdominal drawing-in maneuver exercise for 4 weeks on period 1. afterward washout period in a month, follow period 2 of conventional physiotherapy. on the other side, group b receives first conventional physiotherapy on period 1. afterward washout period in a month, follow period 2 of abdominal drawing-in maneuver exercise.

Eligibility criteria:
inclusion criteria: * the subject consisted of the physician's confirmation of chronic hemiplegia * onset ≥ 6 months * mini-mental state examination≥25 * biceps ≤2, triceps≤2 * ability to sit on a chair alone * fma ue score ≥ 21points, fma ue≤ 60 points exclusion criteria: * biceps\>2, triceps\>2 * flaccid * neglect syndrome * have neurological disease and orthopedic disease * lack of coordination

Keywords: reaching task abdominal drawing-in maneuver adim chronic stroke